Completed

An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

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What is being tested

levalbuterol

Drug
Who is being recruted

Asthma+6

+ Bronchial Diseases

+ Hypersensitivity

Over 12 Years
+31 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: December 2002
See protocol details

Summary

Principal SponsorSumitomo Pharma America, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2002

Actual date on which the first participant was enrolled.

A double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group trial of levalbuterol in subjects 12 years of age and older with asthma. Study participation will include one 1-week single-blind placebo run-in and an 8-week, randomized,double-blind, active-treatment period with four treatment groups. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Official TitleAn Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
NCT00073840
Principal SponsorSumitomo Pharma America, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

386 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AsthmaBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract Diseases

Criteria

12 inclusion criteria required to participate
Must give written informed consent (IC) prior to participation in the study. For subjects 12 - 17 years of age, the IC must be signed parent or legal guardian. Females must sign the Women of Childbearing Potential Addendum
Be willing and able to comply with the study procedures and visit schedules
Male or female, at least 12 years of age
Females 12-60 years of age must have a negative serum pregnancy test at Visit 1 (V1)
Show More Criteria
19 exclusion criteria prevent from participating
Subject who has a history of hospitalization for asthma within 45 days prior to V1, or who is scheduled for in-patient hospitalization during the trial
Subject who is expected to require any disallowed medications
Female subject who is pregnant or lactating
Subject who has participated in an investigational drug study within 30 days prior to V1, or who is currently participating in another clinical trial
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Levalbuterol 90 ųg QID (manufacturing site A or B)

Group II

Active Comparator
Racemic Albuterol 180 ųg QID

Group III

Placebo
Placebo QID

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 54 locations

Suspended

Allergy & Asthma Center, LLC

Oxford, United StatesOpen Allergy & Asthma Center, LLC in Google Maps
Suspended

Alta Clinical Research

Tucson, United States
Suspended

Integrated Research Group

Corona, United States
Suspended

Radiant Research, Inc.

Encinitas, United States
Completed54 Study Centers